Skip to main content
OpenTrials
Completed

NCT Number: NCT02350634

18F-AV-1451 High Resolution Autopsy Study

The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Banner Alzheimer's Institute, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Projected life expectancy ≤ 6 months

Exclusion criteria

  • Primary brain tumor, known metastases to the brain, central nervous system lymphoma
  • Major, focal structural brain lesion
  • Aggressively being treated with life sustaining measures
  • Clinically significant infectious disease
  • History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Females of childbearing potential who are pregnant or not using adequate contraception

Treatment and study plan

Flortaucipir F18

Drug

Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq) (10 millicurie [mCi]) of flortaucipir.

Other names: [F-18]T807, 18F-AV-1451

Primary outcomes

  1. Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region

    Time frame: autopsy within 6 months of scan

    Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

  2. Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region

    Time frame: autopsy within 6 months of scan

    Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of frontal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

  3. Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region

    Time frame: autopsy within 6 months of scan

    Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of parietal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

  4. Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region

    Time frame: autopsy within 6 months of scan

    Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

  5. Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region

    Time frame: autopsy within 6 months of scan

    Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of temporal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

  6. Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region

    Time frame: autopsy within 6 months of scan

    Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of occipital composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

  7. Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region

    Time frame: autopsy within 6 months of scan

    Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of limbic composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2015
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.